Efficacy and Safety of Zolmitriptan by Sublingual Administration

Cluster Headache Clinical Trial

Official title:

Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03377257
• Other study ID #: Xijing-CH-zolmi
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 5, 2017
• Last updated: December 13, 2017
• Start date: January 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2017
• Source: Xijing Hospital
• Contact: Li Li, MD
• Phone: 00862984775365
• Email: lili[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.

Description:

Cluster headache is a primary neurological disorder characterized by intensive attacks and severe sharp headache, can cause a range of symptoms such as conjunctival congestion, runny nose, miosis, forehead sweat. The disability resulting from cluster headache can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using oral zolmitriptan as the control, is to evaluate the effectiveness and safety of zolmitriptan by sublingual administration for the acute treatment of cluster headache. Patients are asked to maintain a headache diary throughout the treatment period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 71
• Est. completion date: April 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients older than or equal to 18 years and less than 70 years;

• The diagnosis of cluster headache is made according to The International Classification of Headache Disorders: 3rd edition (beta version)(ICHD-III ß);

• Consent form signed by the participant or his/her authorized surrogate.

Exclusion Criteria:

• Patients had primary or secondary headache disorders other than cluster headache;

• Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning a pregnancy in the next year or if they were not using an adequate form of birth control;

• Patients will be excluded if they had significant medical or psychiatric disease;

• Patients will be excluded if they had coronary heart disease or not suitable for the treatment of zolmitriptan.

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Drug:
• zolmitriptan by sublingual administration
Experimental group
• zolmitriptan by oral
Active group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet	The difference of the percentage of the headache attacks whose visual analogue scale points reduce from 7-10 to 0-3 5, 10, 15 minutes after administration between sublingual and oral zolmitriptan tablet	5, 10, 15 minutes after administration
Secondary	The percentage of side effects;	The difference of the percentage of side effects in 3 hours after the administration between sublingual and oral zolmitriptan tablet	3 hours
Secondary	The percentage of discontinued the drug	The percentage of discontinued the drug because of side effects	3 days